SYSTANE® BALANCE Symptoms (OSDI) & Inflammatory Biomarkers

Study to Evaluate the Efficacy of SYSTANE® BALANCE in Reducing Symptoms and Inflammatory Biomarker Expression of HLA-DR and Tear Film Cytokines in Dry Eye Subjects With Lipid Deficiency

The purpose of this study is to evaluate the ability of SYSTANE® BALANCE and SYSTANE® Gel to improve comfort in subjects with dry eyes.

Inclusion Criteria:

• Read, sign, and date the Informed Consent Document;
• Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1;
• Meet the protocol-specified dry eye criteria at Screening Visit (Visit 1);
• Intraocular pressure (IOP) less than or equal to 22 millimeters of mercury (mmHg) in both eyes;
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• History or evidence of ocular or intraocular surgery or serious trauma in either eye within the past 6 months;
• Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs);
• History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye;
• Use of any concomitant topical ocular medications during the study period;
• Currently using Restasis but unwilling to discontinue its use 1 month prior to screening and for the entire study period;
• Use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1 and that remains stable throughout the study;
• Uncontrolled ocular conditions such as uveitis, glaucoma or any other ocular condition that may preclude the safe administration of either drop under investigation;
• Other protocol-defined exclusion criteria may apply.